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Randomized Control Trial of Micronized Purified Flavonoid Fraction for Post Operative Treatment in Anal Fistula Surgery

Recruiting
20 - 85 years of age
Both
Phase 4

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Overview

The aim of this study is to evaluate the effect of micronized purified flavonoid fraction on postoperative symptoms after surgery of anorectal fistulas.

Description

The current theory of cryptoglandular suggest that perianal fistula occurs when the anal crypt glands become occluded and infected, over 90% of perianal fistulas are cryptoglandular in origin and arise from perianal abscesses. Also inflammatory process might play an important role in the formation of cryptoglandular perianal fistula. This condition is mainly managed with surgery, currently remain majorly on two conventional surgical interventions--fistulotomy and fistulectomy.

MPFF is a drug to treat venous vessel disease such as varicose and hemorrhoid, which was found with effects of lowering lymphatic permeability, improving venous return and vessel endothelial inflammation. More research has also shown the effects of MPFF on post hemorrhoidectomy symptom control, such as bleeding, pain, and infection. Since other anorectal surgery has similar complications. Therefor we conducted this randomized control trial to evaluate the benefits of MPFF after anal fistula surgeries.

Eligibility

Inclusion Criteria:

  • Patients who undergo fistulectomy or fistulotomy are included.

Exclusion Criteria:

  • Emergency operation
  • Participants who had Trans-sphincteric anal fistula, Extra-sphincteric anal fistula
  • Participants accompanied by severe liver cirrhosis
  • Participants accompanied by coagulation disorders
  • Participants taking anticoagulant
  • Participants taking corticosteroids as long-term medication.
  • Participants who had colorectal cancer
  • Participants taking analgesic drugs (morphine or others) as long-term medication
  • Participants bed-ridden
  • Participants who had history of human immunodeficiency virus (HIV) infection
  • Pregnant woman

Study details

Anal Fistula

NCT06184438

Taipei Medical University Shuang Ho Hospital

30 April 2024

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